Survey of Cancer Patients' Perceptions of Difficulties Encountered When Filling Opioid Prescriptions

• Conditions: Malignant Neoplasm; Pain
• Interventions: Other: Medical Chart Review; Other: Survey Administration

• Registration Number: NCT03989128
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This trial studies the problems that cancer patients face when filling prescriptions for opioids (medications that are used to manage pain). Pain is one of the most common symptoms among cancer patients. Opioid therapy is generally the treatment of choice for adequate management of cancer-related pain. Knowledge of these problems may help health care providers assess the most effective treatment options for cancer patients, and inform policy makers of the adjustments that need to be made to regulations to ensure cancer patients don't lose their access to opioids.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate patients' perceptions of overall difficulties when filling their opioid prescription.

SECONDARY OBJECTIVES:

I. To determine cancer patients' perceptions of financial, logistical, and psychosocial difficulties when filling their opioid prescription.

II. To evaluate the association between patient characteristics and patient difficulty filling opioid prescriptions.

OUTLINE:

Participants complete a survey over 5-10 minutes.

Study Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-18
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-05-29
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients must be on opioids provided by the Supportive Care Center (SCC), and must have visited the SCC 2 previous times for the purpose of opioid pain management. This will ensure that 1) patients will have been told that they are being prescribed an opioid as a treatment for pain, and 2) patients will have gone to a pharmacy to fill their opioid prescription a minimum of one time.
• Patients must be able to understand, read, write, and speak English.
• Patients must sign an informed consent document.
• Patients must have a cancer diagnosis.

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Exclusion Criteria

• Patients who have clinical evidence of cognitive impairment (Memorial Delirium Assessment Scale [MDAS] score of >= 13) as determined by the research staff, treating physician, or nurse.
• Patients who are considered to be in severe physical or emotional distress based on the assessment by the research staff.
• Patients who refuse to participate in the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (survey)	Medical Chart Review	Participants complete a survey over 5-10 minutes
Observational (survey)	Survey Administration	Participants complete a survey over 5-10 minutes

Primary Outcome Measures

Name	Time	Method
Patients' perception of overall difficulties when filling opioid prescriptions	2 years	The proportion of patients who have experienced any difficulty when filling their prescription will be reported along 95% confidence intervals. Association of patients' characteristics with experiencing difficulty will be evaluated by Wilcoxon rank sum test and chi-square (Fisher's exact) test for continuous and categorical variables, respectively.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States